ECG-I Phenotyping of Persistent AF Based on Driver Distribution to Predict Response to Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Freedom from Atrial Arrhythmia and association with distribution of drivers of AF
研究概览
简要总结
Atrial fibrillation (AF) is an irregular heart rhythm associated with significant morbidity and mortality. The pulmonary veins (the blood vessels carrying blood from the lungs into the left atrium) have been shown to send electrical signals into the heart that can cause and maintain AF. Pulmonary vein Isolation (PVI) is an established treatment where catheters are passed into the atria of the heart to deliver lines of scar to electrically isolate the pulmonary veins preventing them from transmitting these electrical signals into the left atrium.
The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.
Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically.
The investigators intend to enroll 100 patients with persistent AF and perform atrial mapping using the ECG-I system. Solely pulmonary vein isolation will be performed. Patients will be followed up to see if the distribution of drivers as predicted by the ECG-I predicts outcomes. This may improve patient selection for this procedure.
详细描述
Atrial Fibrillation (AF) is the commonest heart rhythm disturbance and is associated with significant morbidity and mortality. Catheter ablation (CA) is a procedure where catheters (leads) are passed into the heart and energy is used to disrupt and isolate (by freezing or cauterising) heart tissue causing AF. CA is an established therapy for AF. Success rates for CA for paroxysmal AF lies in the region of 70% or better. However, success rates for persistent AF is much lower and estimates lie in the region of 30-60%.
Current CA protocols for AF centre on isolating the pulmonary veins (the pulmonary veins drain into the left atrium) which have been proven to trigger AF. Pulmonary Vein Isolation (PVI) ablation alone seems sufficient to remove the trigger for the vast majority of patients with paroxysmal AF. However, in patients with persistent AF it is common for AF to continue after the pulmonary veins have been electrically isolated.
The difference in success rates between the paroxysmal and persistent form of AF is thought to be due to changes within the heart atria after AF has been established for some time. In persistent AF the atria dilate and remodel structurally and electrically, and therefore the maintenance of persistent AF differs from paroxysmal AF.
Persistent AF is thought to be maintained by focal sources, whether rotors or sites of radial activation. Currently, targeting other sites within the atria in addition to PVI such as fractionated electrograms (areas of electrical activity) are thought to be imprecise and require extensive ablation. Often AF will persist despite targeting additional sites within the atria.
One particular challenge is to select patients likely to benefit from CA. CA carries an approximate less than 1% risk of life threatening complication. Therefore being able to select suitable patients is desirable in order to prevent unnecessary procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Persistent AF (i.e. episodes of AF that are continuous for > 1 week or have required DC cardioversion)
- •Willing for ablation.
- •Age between 18 to
- •left atrial diameter <5 cm
- •left ventricular function >40%.
- •New York Heart Association class < 3.
排除标准
- •Persistent AF diagnosed > 2 years ago
- •left atrial diameter > 5 cm
- •Severe left ventricular impairment (EF < 40%)
- •New York Heart Association class 3 or 4 heart failure
- •Known hypertrophic cardiomyopathy, cardiac sarcoid, or arrythmogenic ventricular cardiomyopathy.
- •Known inherited arrhythmia such as Brugada or long QT syndromes
- •Valvular disease that is more than moderate
- •History of valve replacement (metallic or tissue)
- •History of congenital heart disease (other than patent foramen ovale)
- •Previous left atrial ablation (percutaneous or surgical)
- •Cardiac surgery or percutaneous coronary intervention within the last 3 months.
- •Myocardial infarction or unstable angina within the last 3 months.
- •Unwillingness for ablation
- •Unwillingness to be involved in study
- •Suspected reversible cause of AF
- •Any other contraindication to catheter ablation
- •Age < 18 yrs or > 80 years
- •Pregnancy
- •Morbid obesity (defined as BMI >40)
- •Any other medical problem likely to cause death within the next 18 months
研究组 & 干预措施
ECG-I mapping and PVI
ECG-I mapping and PVI
干预措施: ECG-I mapping and PVI (Device)
结局指标
主要结局
Freedom from Atrial Arrhythmia and association with distribution of drivers of AF
时间窗: Performed 12-14 months post procedure
All patients will undergo mapping with ECG-I during their procedure. The number of drivers and their locations will be collected. Patients who remain free from AF at 12 months will be compared to patients who relapsed comparing the number and location of these drivers.
次要结局
- Impact of pulmonary vein isolation on drivers of AF(During AF Catheter Ablation)